BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINAL IMPACTOR

    MDR report key: 8903127 · Received August 16, 2019

    Report

    Report Number
    3010536692-2019-00999
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    June 3, 2019
    Report Date
    August 6, 2019
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HWA
    UDI-DI
    M684APA090281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY DEFORMATION OF THE TIP. SURGERY WAS EXTENDED GREATER THAN 30 MINUTES. KIT NUMBER: PRGLKIT4; KIT LOT NUMBER: G180963.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695438 FINAL IMPACTOR HIP INSTRUMENT HWA MICROPORT ORTHOPEDICS INC. APA09028 CN151526 M684APA090281

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention